Suprachoroidal Injection of CLS-TA in Patients With Non-infectious Uveitis

NCT03097315 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CLS1001-302
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 10

Brief Summary

This open-label study is designed to evaluate the safety of suprachoroidally administered triamcinolone acetone injectable suspension, CLS-TA, in patients with non-infectious uveitis with and without macular edema.

Conditions

Uveitis; Uveitis, Posterior; Uveitis, Anterior; Uveitis, Intermediate; Panuveitis

Keywords

Uveitis; UME; Posterior Uveitis; Anterior Uveitis; Intermediate Uveitis; Panuveitis; Non-infectious Uveitis; Triamcinolone; Choroid; Choroidal Injection; Suprachoroidal; Microneedle; Microinjection; Triamcinolone acetonide

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Number of patients with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). An adverse event (AE) is the development of an undesirable medical condition or the deterioration of a preexisting medical condition after or during exposure to a pharmaceutical product, whether or not considered causally related to the product. A TEAE is an AE occurring on or after the date of the first dose of study drug or worsening relative to the pre-treatment state. An SAE is an AE that fulfils one or more of the following: results in death; is immediately life-threatening; requires hospitalization nor prolongation of hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; or is an important medical event that may jeopardize the subject or may require medical intervention to present one of the outcomes listed above.

  Baseline to 24 weeks

Secondary Outcomes (4)

• Mean Intraocular Pressure in the Study Eye

  Baseline, 24 Weeks

• Number of Patients With a Grade of 0 in Anterior Chamber Cells in the Study Eye

  Baseline, 24 Weeks

• Number of Patients With a Grade of 0 in Anterior Chamber Flare in the Study Eye

  Baseline, 24 Weeks

• Number of Patients With a Grade of 0 in Vitreous Haze in the Study Eye

  Baseline, 24 Weeks

Study Arms (1)

4 mg CLS-TA Suprachoriodal Injection

EXPERIMENTAL

Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA

Drug: 4 mg CLS-TA Suprachoriodal Injection

Interventions

4 mg CLS-TA Suprachoriodal Injection DRUG

CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints

Also known as: Triamcinolone Acetonide

4 mg CLS-TA Suprachoriodal Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of active or inactive non-infectious uveitis (pan, anterior, intermediate and posterior)
• ETDRS BCVA score of ≥ 5 letters read in the study eye

You may not qualify if:

• Any active ocular disease or infection in the study eye other than uveitis
• Intraocular pressure \> 22 mmHg or uncontrolled glaucoma in the study eye; patients with IOP of 22 or less in the study eye not excluded with no more than 2 IOP-lowering medications.
• Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study
• Any topical ocular corticosteroid in the 10 days prior to baseline; intraocular or periocular corticosteroid injections in the 2 months prior to baseline; an OZURDEX implant in the 6 months prior to baseline; RETISERT or ILUVIEN implant in the 3 years prior to baseline.

Sponsors & Collaborators

• Clearside Biomedical, Inc.: lead

Study Sites (10)

Retinal Consultants of Arizona

Phoenix, Arizona, 85014, United States

Location

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Northern California Retina Vitreous Associates Medical Group, Inc.

Mountain View, California, 94040, United States

Location

Retina Group of Florida

Fort Lauderdale, Florida, 33308, United States

Location

Marietta Eye Clinic

Marietta, Georgia, 30060, United States

Location

Midwest Eye Retina Practicing at Midwest Eye Institute

Indianapolis, Indiana, 46290, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Texas Retina Associates

Dallas, Texas, 75231, United States

Location

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

Virginia Eye Consultants

Norfolk, Virginia, 23502, United States

Location

Related Publications (5)

• Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016/j.ajo.2005.03.057.

  PMID: 16196117 BACKGROUND

• Nussenblatt RB, Palestine AG, Chan CC, Roberge F. Standardization of vitreal inflammatory activity in intermediate and posterior uveitis. Ophthalmology. 1985 Apr;92(4):467-71. doi: 10.1016/s0161-6420(85)34001-0.

  PMID: 4000641 BACKGROUND

• Lowder C, Belfort R Jr, Lightman S, Foster CS, Robinson MR, Schiffman RM, Li XY, Cui H, Whitcup SM; Ozurdex HURON Study Group. Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis. Arch Ophthalmol. 2011 May;129(5):545-53. doi: 10.1001/archophthalmol.2010.339. Epub 2011 Jan 10.

  PMID: 21220619 BACKGROUND

• Yeh S, Ciulla T. Suprachoroidal triamcinolone acetonide injectable suspension for macular edema associated with noninfectious uveitis: an in-depth look at efficacy and safety. Am J Manag Care. 2023 Feb;29(2 Suppl):S19-S28. doi: 10.37765/ajmc.2023.89324.

  PMID: 36787524 DERIVED

• Yeh S, Henry CR, Kapik B, Ciulla TA. Triamcinolone Acetonide Suprachoroidal Injectable Suspension for Uveitic Macular Edema: Integrated Analysis of Two Phase 3 Studies. Ophthalmol Ther. 2023 Feb;12(1):577-591. doi: 10.1007/s40123-022-00603-x. Epub 2022 Nov 18.

  PMID: 36399237 DERIVED

MeSH Terms

Conditions

Uveitis; Uveitis, Posterior; Uveitis, Anterior; Uveitis, Intermediate; Panuveitis

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Thomas Ciulla, MD MBA
• Organization: Clearside Biomedical, Inc.

thomas.ciulla@clearsidebio.com

(678) 392-2318

Study Officials

• Thomas Ciulla, MD

  Clearside Biomedical, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: March 31, 2017
• Study Start: April 4, 2017
• Primary Completion: January 24, 2018
• Study Completion: January 24, 2018
• Last Updated: June 23, 2021
• Results First Posted: June 15, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)